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Regulatory Data Use and Integrity across Stakeholders
Session Chair(s)
Peter Bachmann
Retired from Head International Liaison Office and Conferences, Executive Depart
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Christa Wirthumer-Hoche, PhD
Retired
Austria
• Electronic optimisation and recent regulatory updates (e.g. SPOR, IRIS, Telematics strategy) • Ensure data use efficiencies and integrity across stakeholders • Technological advancements in regulatory systems
Speaker(s)
EMA’s Telematics Strategy/SPOR
Niels Leander, PhD
Eraneos, Denmark
Partner - Life Sciences
The Importance of Data Modelling for Successful Regulatory Affairs Units
Joerg Stueben, DrSc
Boehringer Ingelheim International Gmbh, Germany
Head of Regulatory Information Management
Regulator Data Exchange Projects within EU
Laurent Desqueper
-, Belgium
IDMP Business Data Lead
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